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FDA 510(k)

Revitive Medic Plus, Revitive Advanced 2

K-Number: K190924 · 2019-07-05

ApplicantActegy , Ltd.
Decision Date2019-07-05
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Revitive Medic Plus, Revitive Advanced 2 is the device name listed in this FDA 510(k) record. The listed applicant is Actegy , Ltd.. It received FDA 510(k) clearance on 2019-07-05 under 510(k) number K190924. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Revitive Medic Plus, Revitive Advanced 2?

Revitive Medic Plus, Revitive Advanced 2 is a medical device that received FDA 510(k) clearance on 2019-07-05. The listed applicant is Actegy , Ltd.. The 510(k) number is K190924.

When did Revitive Medic Plus, Revitive Advanced 2 receive FDA 510(k) clearance?

Revitive Medic Plus, Revitive Advanced 2 received FDA 510(k) clearance on 2019-07-05, under 510(k) number K190924.

Who is the listed applicant for Revitive Medic Plus, Revitive Advanced 2?

The FDA 510(k) record lists Actegy , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Revitive Medic Plus, Revitive Advanced 2?

The FDA product code for Revitive Medic Plus, Revitive Advanced 2 is NGX.

Other records listing Actegy , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210825Revitive Medic Coach (Model Number 5575AQ)K192887Revitive Medic Plus, Revitive Advanced 2K152480Revitive Medic; Revitive MV; Revitive LV

Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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